Efficacy of a homeopathic Crataegus preparation compared with usual therapy for mild (NYHA II) cardiac insufficiency: results of an observational cohort study.

OBJECTIVES To compare the efficacy of the homeopathic Crataegus preparation Cralonin for non-inferiority to standard treatment for mild cardiac insufficiency. METHODS Multicentre non-randomised cohort study in patients aged 50-75 years in New York Heart Association class II. Patients received Cralonin (n=110) or ACE inhibitor/diuretics (n=102) for 8 weeks. To adjust for confounding by baseline factors, populations were stratified according to propensity score. After adjusting, there were no statistically significant differences between treatment groups. Treatment efficacy was assessed on 15 variables. A stringent non-inferiority criterion for the upper limit of the 97.5% one-sided confidence interval of the treatment difference was set to 0.2x the standard deviation (S.D.). RESULTS Both treatment regimens improved scores on most variables studied, with the greatest effect on double product after exercise (average score reduction 15.4% with Cralonin vs. 16.0% for the control group). Stringent non-inferiority of Cralonin was demonstrated on 7 variables. Medium-stringent (0.5xS.D.) non-inferiority was indicated by 13 variables (exceptions: systolic blood pressure (BP) during exercise and diastolic BP at rest; for these, differences between treatments were not significant). Both treatments were well tolerated. CONCLUSION The Crataegus-based preparation Cralonin is non-inferior to usual ACE inhibitor/diuretics treatment for mild cardiac insufficiency on all parameters except BP reduction.